Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— Coca-Colon  

Official title:

Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212510
• Other study ID #: 2009/170/HP
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: August 16, 2016
• Start date: October 2010
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

Description:

Prospective cohort study of patients treated with systemic chemotherapy for unresectable metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer has been published (J Clin Oncol 2008;26:3681-6). The present study is designed to validate the previous data. The secondary purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy. Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy and biotherapy validate in this clinical situation by the French National Cancer Institute (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC will be performed at day 1 and 42 of chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patient has Stage IV colorectal adenocarcinoma histologically proved

• Patient has at least one measurable lesion

• Patient has performance status 0-2 on the WHO performance scale

• Patient is male or female, and > 18 years of age

• Patient has agree to participate by giving written informed consent

Exclusion Criteria:

• Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Blood sampling
blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	University Hospital	Caen
France	Centre Frédéric Joliot	Rouen
France	University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of tumor progression	sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)	3 months	No
Secondary	Prediction of tumor response	sensitivity and specificity of CEA kinetic to predict tumor response at 3 months (RECIST)	3 months	No